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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEARTMATE IP AND VE LVAS
Generic NameVentricular (assist) bypass
ApplicantTHORATEC CORP.
6035 STONERIDGE DR.
PLEASANTON, CA 94588
PMA NumberP920014
Supplement NumberS010
Date Received12/01/1999
Decision Date12/10/1999
Withdrawal Date 10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft.
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